Table 1.
Site Characteristics (N = 27) | Median | Range |
---|---|---|
Annual analytic cases | 1,871 | 526-3,585 |
Population | ||
Urban | 71% | 0-100 |
Rural | 29% | 0-100 |
Race/ethnicity | ||
White | 81% | 25-97 |
African American | 8% | <1-52 |
Asian | 2% | 0-54 |
Hawaiian/Pacific Islander | 0% | 0-18 |
American Indian/Alaska Native | 0% | 0-2 |
Hispanic/Latino | 5% | 0-52 |
Data management | ||
Electronic medical record | 70% | |
Clinical data management systems | 81% | |
Electronic data capture | 100% | |
Infrastructure, percentage of sites | ||
Biopsy: additional biopsy capability | 89% | |
Clinical research unit (for any type of trial, including cancer) | 19% | |
Freezer: −80°C to −20°C freezer for specimens | 89% | |
Freezer: standard freezer for specimens | 100% | |
PK/PD capability | 85% | |
Pharmacy with experience with investigational agents | 100% | |
Radiation therapy on site | 96% | |
Refrigerator for specimens | 100% | |
Specific inpatient accommodations for clinical trials (eg, dedicated beds) | 33% | |
Specimens: capacity to collect, handle, and send | 100% | |
Staffing† | ||
Regulatory | ||
Institutional review board turnaround time, days | 45 | 7-71 |
Institutional biosafety committee utilized, percentage of sites | 30% | |
Trial sponsors, percentage of sites | ||
Sites with Cooperative Group EP trials open | 93% | |
Sites with industry EP trials open | 81% | |
Sites with NCI-designated cancer center EP trials open | 48% | |
Sites with local EP trials open | 22% | |
Collaborations with NCI programs, percentage of sites | ||
Cooperative Group membership | 100% | |
Use of NCI Cancer Trials Support Unit for EP participation | 70% | |
NCI CCOP | 48% | |
Funding source distribution‡ | ||
Cancer center | 0% | 0%–50% |
Federal | 41% | 0%–82% |
Hospital | 0% | 0%–99% |
Industry | 26% | 0%–65% |
Philanthropy | 0% | 0%–80% |
Trial composition per site | ||
No. of EP trials open per site during July 2010-June 2011 | 19 | 1-66§ |
Proportion of sponsor's trials per site | ||
Cooperative Groups | 76% | 0%–100% |
Industry | 13% | 0%–78% |
Local | 0% | 0%–17% |
NCI-designated cancer centers | 1% | 0%–43% |
Other | 0% | 0%–12% |
Accrual to EP trials per site in 1 year | ||
No. accrued | 14 | 0-67 |
Rate (No. accrued/1,000 new analytic cases) | 7 | 0-67 |
Abbreviations: CCOP, Community Clinical Oncology Program; CTEP, Cancer Therapy Evaluation Program; EP, early-phase; NCI, National Cancer Institute; PK/PD, pharmacokinetic/pharmacodynamic.
For 27 responding sites.
Please see Results and Discussion sections.
Three responding sites did not answer this question.
Number of open EP trials at a site may also reflect EP trials open at a lead site (eg, a lead CCOP site) with which that National Cancer Institute Community Cancer Centers Program site is affiliated.